Gilead’s Kite Pharma gets FDA nod for second CAR-T cell therapy

The agency approved Tecartus, previously developed under the name KTE-X19, as the first CAR-T therapy for mantle cell lymphoma. The company had previously won approval for another CAR-T, Yescarta. Tecartus is a similar product, but with a different manufacturing process.

By ALARIC DEARMENT

Post a comment / Jul 24, 2020 at 2:06 PM

One of the first companies to win Food and Drug Administration approval for a CAR-T cell therapy has received the agency’s nod for its second product.

Kite Pharma, a subsidiary of Foster City, California-based Gilead Sciences, said Friday that the FDA had given accelerated approval to Tecartus (brexucabtagene autoleucel) as the first CAR-T cell therapy approved for mantle cell lymphoma, an indolent – or slow-growing – form of non-Hodgkin’s lymphoma. Kite had previously received approval for its first CAR-T, Yescarta (axicabtagene ciloleucel), for diffuse large B-cell lymphoma; Tecartus is a similar product to Yescarta and targets the same antigen, CD19, but uses a different manufacturing process, hence the different branding.

This Car-T is still in its infancy. It would be good if they have found a better way for using it.